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Clinical Trial Summary

studying if using extracorporeal radial shockwave therapy as an adjuvant therapy help in accelerating the bone healing and regeneration in mandibular fractures by comparing it with the standard protocol for fractures fixation by plates and screws.


Clinical Trial Description

Firstly the patient heads to the operating room being placed in a supine position, generally anesthetized by the anesthesiologist. Sterilization of intraoral and extraoral sites and draping has been installed. Intermaxillary fixation (IMF) screws has been inserted in case of there is no arch bar is used. If the arch bar has been used it was inserted before the operation and being cut at the fracture line between the two segments. The transoral or extra-oral approach is utilized to expose the fracture line separating the two segments. Fixation of the bony segments with two plates one Compression 2.3 plate at the inferior border and Tension 2.0 plate five millimeter superiorly to the compression plate. or even one 2.0 plate(champy) Then suturing the incision layers with vicryl 3/0. Postoperative evaluation with cone beam computed tomography (CBCT). These procedures will be done for both groups. The control group with no adjuvant intervention will stop at this point. The other intervention group will be subjected to shockwave by the usage of extracorporeal shockwave device at the third day postoperative. Then follow up at the first and fourth month with another CBCT to compare the bone healing at the fracture site. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06363188
Study type Observational
Source Cairo University
Contact khloud nasr el-din, GP.
Phone 01014919174
Email khloud.ahmed@dentistry.cu.edu.eg
Status Recruiting
Phase
Start date February 1, 2024
Completion date August 30, 2025